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National Defense Magazine Features Eye-Opening FCPA Article by John Renzulli and Michael Patrick

National Defense Magazine, one of the major publications in the defense industry, featured John Renzulli and Michael Patrick's article Defense Contractors Increasingly Targeted in Corruption Investigations in its August 2010 issue.

The article addresses the exploding costs associated with bribery and corruption around the world, and especially in the United States under the Foreign Corrupt Practices Act (or FCPA). Mr. Renzulli and Mr. Patrick explain in the article that the key to avoiding the high costs associated with bribery and corruption and, indeed, even just the allegations of bribery or corruption, is to effectively address risks through stringent, comprehensive compliance programs.

Mr. Renzulli and Mr. Patrick assist corporations in designing and implementing compliance programs that are tailored to the individual corporation's needs and budget. For more information, please contact John Renzulli or Michael Patrick.

Christopher Renzulli and John Tait Featured in DRI's FOR THE DEFENSE Magazine

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Download the Article Here	621 Kb

Supreme Court Applies the Second Amendment to the States in McDonald v. Chicago

On June 28, 2010, the United States Supreme Court issued its decision in the McDonald v. Chicago case, holding that the Second Amendment right to keep and bear arms was incorporated through the Fourteenth Amendment and is fully applicable to the states.

On June 26, 2008, the Supreme Court issued its decision in District of Columbia v. Heller, holding that the Second Amendment protects an individual right to keep and bear arms and, on that basis, striking down the District of Columbia’s ban on possessing a handgun in the home. The decision in District of Columbia v. Heller, however, only applied to federal gun control laws. In its McDonald decision, the Court addressed the issue of whether the Second Amendment also applies to state and local laws through the Fourteenth Amendment, which states in relevant part that: “No State shall make or enforce any law which shall abridge the privileges or immunities of citizens of the United States; nor shall any State deprive any person of life, liberty, or property, without due process of law. . . .” The first clause is known as the privileges and immunities clause; the second is known as the due process clause.

Justice Alito wrote the opinion of the Court, which was joined by Chief Justice Roberts and Justices Scalia and Kennedy. Justice Thomas joined in the judgment, and certain parts of Justice Alito’s opinion. Justice Scalia wrote a concurring opinion and Justice Thomas wrote an opinion concurring in part and concurring in the judgment. Justice Stevens wrote a dissenting opinion and Justice Breyer wrote a dissenting opinion in which Justices Ginsburg and Sotomayor joined.

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Supreme Court's Decision in McDonald v. Chicago	1111 Kb

H.R. 6381: Will Congress Strip Class III Medical Device Manufacturers of Their Pre-Emption Defenses?

In its February 20, 2008 decision in Riegel v. Medtronic, Inc., 552 U.S. 312, 128 S.Ct. 999, 169 L.Ed.2d 892 (2008) the United States Supreme Court affirmed that the express pre-emption clause in the Medical Device Amendments (MDA) of 1976, 21 U.S.C. § 360k(a), completely bars certain lawsuits against Class III medical device manufacturers. Just a few months after Riegel was handed down, a bill designed to overrule this decision was introduced in the House of Representatives. This article analyzes Riegel and tracks the legislative efforts to undermine this decision by amending the MDA to allow state common-law claims against Class III medical device manufacturers.

The plaintiffs in Riegel filed a civil lawsuit against Medtronic, Inc. in which they claimed that a balloon catheter that ruptured during the course of an angioplasty was negligently and defectively designed, tested, manufactured, and labeled. Prior to the incident, Medtronic, Inc. sought and obtained premarket approval from the Food and Drug Administration (FDA) to market this catheter as a Class III medical device under the MDA. The “rigorous” premarket approval process requires the manufacturer to submit an application that contains, among other things, detailed information on the device’s safety and effectiveness. The FDA spends an average of 1,200 hours reviewing each premarket approval application and only grants premarket approval if it finds there is a reasonable assurance of the device’s safety and effectiveness. 21 U.S.C. § 360e(d). More information on the premarket approval process can be found on the FDA’s website.

Analysis of the reporting requirements of the Medicare, Medicaid and SCHIP Extension Act of 2007

As of January 1, 2010, new reporting requirements took effect involving the payment of a settlement or judgment to a Medicare beneficiary. The following is a brief summary of the new reporting requirements.

Background

In 1980, the Medicare Secondary Pay Act (“MSP”) was enacted to amend the 1965 Social Security Act. The MSP prohibited Medicare from reimbursing medical benefits where payment has been made or can reasonably be expected to be made “under a workers’ compensation law, or other private insurance plans.” Thus, Medicare was no longer a primary payer for a Medicare beneficiary’s medical costs.

Renzulli Law Firm

National Defense Magazine Features Eye-Opening FCPA Article by John Renzulli and Michael Patrick

Christopher Renzulli and John Tait Featured in DRI's FOR THE DEFENSE Magazine

Supreme Court Applies the Second Amendment to the States in McDonald v. Chicago

H.R. 6381: Will Congress Strip Class III Medical Device Manufacturers of Their Pre-Emption Defenses?

Analysis of the reporting requirements of the Medicare, Medicaid and SCHIP Extension Act of 2007

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